Process for formulating fast dispersing dosage forms comprising at least one fish gelatin selected on the basis of molecular weight

Abstract

The invention disclosed herein relates to a pharmaceutical composition comprising a carrier and an active ingredient, wherein the carrier is at least one fish gelatin predetermined on the basis of the molecular weight profile of the gelatin. In some embodiments, particularly when the concentration of carrier comprises a relatively lower percentage of the total composition, the carrier may be exclusively a high molecular weight fish gelatin, or may be comprised of a mixture with standard molecular weight gelatin in which high molecular weight gelatin comprises a predominant portion. In those embodiments where the concentration of carrier comprises a relatively larger percentage of the total composition, the carrier may be an exclusively standard molecular weight fish gelatin, or may be comprised of a mixture in which standard molecular weight gelatin comprises a predominant portion. Thus, compositions may be designed to optimize performance for various required gelatin concentration formulations.

1. A process for preparing a pharmaceutical composition in a fast dispersing dosage form containing at least one active ingredient and at least one carrier comprising the steps of:
 selecting the at least one carrier based at least in part on the molecular weight profile of the carrier and a predetermined final total gelatin concentration between 3.5% and 6.0% w/w of the composition, 
 wherein the at least one carrier is inert to the active ingredient and wherein the at least one carrier is a combination of high molecular weight fish gelatin and standard molecular weight fish gelatin, and 
 wherein the ratio of high molecular weight fish gelatin to standard molecular weight fish gelatin is 50:50 to 10:90; 
 forming a mixture of the at least one active ingredient and the at least one carrier in a suitable solvent to create a formulation; 
 cooling the formulation to an intermediate formulation dosing temperature; 
 dosing the formulation into discrete units at the intermediate formulation dosing temperature; 
 solidifying the discrete units; and 
 removing the solvent from the solid discrete units to form a network of the at least one active ingredient and the at least one carrier; 
 wherein the formulation has a total viable count of less than 1000 cfu/ml; 
 wherein the solid discrete units have an acceptable surface appearance; 
 wherein the formulation exhibits a fairly constant viscosity over a period of about 48 hours; and 
 wherein the high molecular weight fish gelatin is a fish gelatin in which more than 50% of the molecular weight distribution is greater than 30,000 daltons and the standard molecular weight fish gelatin is a fish gelatin in which more than 50% of the molecular weight distribution is below 30,000 daltons. 
 
     
     
       2. The process according to  claim 1 , wherein the fish gelatin is a non-gelling fish gelatin at room temperature. 
     
     
       3. The process according to  claim 1 , wherein the fish gelatin is non-hydrolyzed. 
     
     
       4. The process according to  claim 1 , wherein the solvent is water. 
     
     
       5. The process according to  claim 1 , wherein the solvent is removed from the discrete units by freeze-drying. 
     
     
       6. The process according to  claim 1 , wherein the solvent is removed from the discrete units by forced-air drying. 
     
     
       7. The process according to  claim 1 , wherein the solvent is removed from the discrete units by a second solvent removal process. 
     
     
       8. The process according to  claim 1 , wherein the high molecular weight fish gelatin is a fish gelatin in which more than 60% of the molecular weight distribution is greater than 30,000 daltons. 
     
     
       9. The process according to  claim 1 , wherein the high molecular weight fish gelatin is a fish gelatin in which more than 70% of the molecular weight distribution is greater than 30,000 daltons. 
     
     
       10. The process according to  claim 1 , wherein the standard molecular weight fish gelatin is a fish gelatin in which more than 60% of the molecular weight distribution is below 30,000 daltons. 
     
     
       11. The process according to  claim 1 , wherein the standard molecular weight fish gelatin is a fish gelatin in which more than 70% of the molecular weight distribution is below 30,000 daltons. 
     
     
       12. The process according to  claim 1 , wherein the combination of high molecular weight and standard molecular weight gelatin contains more than 50% w/w high molecular weight gelatin. 
     
     
       13. The process according to  claim 8 , wherein the combination of high molecular weight and standard molecular weight gelatin contains more than 50% w/w standard molecular weight gelatin. 
     
     
       14. The process according to  claim 1 , wherein the combination of high molecular weight and standard molecular weight gelatin contains high molecular weight gelatin and standard molecular weight gelatin in substantially the w/w ratio 1:1. 
     
     
       15. The process according to  claim 1 , wherein the combination of high molecular weight and standard molecular weight gelatin contains high molecular weight gelatin and standard molecular weight gelatin in substantially the w/w ratio 1:2. 
     
     
       16. The process according to  claim 1 , wherein the combination of high molecular weight and standard molecular weight gelatin contains high molecular weight gelatin and standard molecular weight gelatin in substantially the w/w ratio 1:3. 
     
     
       17. The process according to  claim 1 , wherein the combination of high molecular weight and standard molecular weight gelatin contains high molecular weight gelatin and standard molecular weight gelatin in substantially the w/w ratio 1:9. 
     
     
       18. The process according to  claim 1 , wherein the composition is designed for oral administration and releases the active ingredient rapidly in the oral cavity. 
     
     
       19. The process according to  claim 1 , wherein the composition disperses within 1 to 30 seconds of being placed in contact with fluid. 
     
     
       20. The process according to  claim 1 , wherein the composition disperses within 1 to 20 seconds of being placed in contact with fluid. 
     
     
       21. The process according to  claim 1 , wherein the composition disperses within 1 to 10 seconds of being placed in contact with fluid. 
     
     
       22. A solid, oral, rapidly disintegrating dosage form of a pharmaceutically active substance prepared by a process according to  claim 13 , which may also contain at least one additional ingredient selected from the group consisting of coloring agents, flavoring agents, excipients, and multiple therapeutic agents. 
     
     
       23. A solid, oral, rapidly disintegrating dosage form of a pharmaceutically active substance prepared by a process according to  claim 1 . 
     
     
       24. A solid, oral, rapidly disintegrating dosage form of a pharmaceutically active substance prepared by a process according to  claim 8 . 
     
     
       25. A solid, oral, rapidly disintegrating dosage form of a pharmaceutically active substance prepared by a process according to  claim 9 . 
     
     
       26. A solid, oral, rapidly disintegrating dosage form of a pharmaceutically active substance prepared by a process according to  claim 10 . 
     
     
       27. A solid, oral, rapidly disintegrating dosage form of a pharmaceutically active substance prepared by a process according to  claim 11 . 
     
     
       28. A solid, oral, rapidly disintegrating dosage form of a pharmaceutically active substance prepared by a process according to  claim 12 . 
     
     
       29. A solid, oral, rapidly disintegrating dosage form of a pharmaceutically active substance prepared by a process according to  claim 13 . 
     
     
       30. A solid, oral rapidly disintegrating dosage form of a pharmaceutically active substance prepared by a process according to  claim 14 . 
     
     
       31. A solid, oral rapidly disintegrating dosage form of a pharmaceutically active substance prepared by a process according to  claim 15 . 
     
     
       32. A solid, oral rapidly disintegrating dosage form of a pharmaceutically active substance prepared by a process according to  claim 16 . 
     
     
       33. A solid, oral rapidly disintegrating dosage form of a pharmaceutically active substance prepared by a process according to  claim 17 .